ENDOPATH 5BBRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705036000761), received between May 16, 2018 and Aug 8, 2024 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 8, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE FELL APART. UNKNOWN HOW THE CASE WAS COMPLETED. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19943019 ↗
• MalfunctionJun 18, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE PACKAGING HAD ¿PUNCTURE HOLES¿ IN IT. NOTICED WHEN OPENING THE DEVICE. DEEMED NOT STERILE, SO DID NOT USE. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19562492 ↗
• InjuryApr 9, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A RELATED RESEARCH ACTIVITY DATABASE (DRRA) FOR PATIENTS UNDERGOING UNKNOWN PROCEDURE. EVALUATION OF OUTCOMES OF ENDOPATH ENDOSCOPIC HAND INSTRUMENTS. PRESENCE OF AN ICD-9/10-CM PRIMARY OR SECONDARY DIAGNOSIS CODE FOR ACCIDENTAL PUNCTURE OR LACERATION DURING THE INDEX ADMISSION. ICD-9/10-CM PRIMARY OR SECONDARY DIAGNOSIS CODE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 19072267 ↗
• MalfunctionDec 21, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE JAW WAS BENT BEFORE USE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. PATIENT CONSEQUENCE WAS NOT REPORTED. DID THE EVENT OCCUR DURING STERILE PROCESSING? UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11049651 ↗
• MalfunctionNov 4, 2020Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE CUSTOMER RECEIVED A BOX OF SIX, AND ONE OF THE DEVICES HAD A HOLE IN THE PACKAGING. PATIENT CONSEQUENCE WAS NOT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10789282 ↗
• MalfunctionDec 10, 2019Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, AS THE SURGEON ATTEMPTED TO GRASP THE EEA SIZER, THE END OF THE BABCOCK BROKE OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIKE DEVICE WITH NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9448706 ↗
• MalfunctionDec 10, 2019Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, AS THE SURGEON ATTEMPTED TO GRASP THE EEA SIZER, THE END OF THE BABCOCK BROKE OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIKE DEVICE WITH NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9448702 ↗
• MalfunctionDec 10, 2019Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, AS THE SURGEON ATTEMPTED TO GRASP THE EEA SIZER, THE END OF THE BABCOCK BROKE OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIKE DEVICE WITH NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9448693 ↗
• MalfunctionMay 16, 2018Break

  IT WAS REPORTED THAT THE JAW PART IS BROKEN AND CANNOT BE INSERTED INTO TROCAR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7519399 ↗